FDA device listing
ECHELON 3000 45mm Stapler; ECHELON 3000 60mm Stapler
FDA device listing 1045791338 · ETHICON ENDO-SURGERY, INC.
Key facts
| Proprietary names | ECHELON 3000 45mm Stapler; ECHELON 3000 60mm Stapler |
|---|---|
| Owner/operator | ETHICON ENDO-SURGERY, INC. |
| Owner/operator number | 9010225 |
| Product codes | GAG |
| Device names | GAG - Stapler, Surgical |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4740 |
| Review panels | General Hospital |
| Registered establishments | ETHICON ENDO-SURGERY S.A. DE C.V. PLANTA II |
| Establishment registrations | 9710649 |
| FEI numbers | 3003565435 |
| Establishment operations | Contract Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database